©EMILLECT 2024/2025 ACADEMIC YEAR. ALL RIGHTS RESERVED
FIRST PUBLISH OCTOBER 2024
FDSCTE 5310 mid3 Exam Study Guide
Solutions
definition and goals of product recall (4) - ANSWER✔✔-process of removing an unsafe product from the
marketplace, stop delivery and sale of the product, inform regulatory agencies, timely removal of
product
reasons to recall (11) - ANSWER✔✔-chemical contamination, in-house sabotage, tampering, illness
patterns from CDC, supplier notification, foreign objects, company generated information, misbranding,
scientific reports, fraudulent consumer claims, communicable diseases
agencies that oversee recalls (8) - ANSWER✔✔-company, FDA, FSIS, CDC, USDA, local and state health
agencies, FBI, EPA
classification and criteria for recalls (3) - ANSWER✔✔-class 1 (serious adverse health effects or death
possible), class 2 (health hazard may exist but chances are remote), class 3 (consumption of product not
likely to cause harm)
FDA recall initiation types (3) - ANSWER✔✔-voluntary, FDA request, FDA mandate
aspects of recall plans (4) - ANSWER✔✔-complaint, traceability, record keeping, testing
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, ©EMILLECT 2024/2025 ACADEMIC YEAR. ALL RIGHTS RESERVED
FIRST PUBLISH OCTOBER 2024
difference between quality assurance and quality control (1) - ANSWER✔✔-quality control focuses on
product while quality assurance focuses on the process
important quality systems (9) - ANSWER✔✔-ANSI, Malcolm Baldridge National Quality Awards, HACCP
(FSMA and HARPC), GMP, Lean manufacturing, TQM, ISO 9000, Six Sigma, Codex alimentarius
acronym and mission of ANSI - ANSWER✔✔-American National Standards Institute, promote and
facilitate voluntary consensus standards and conformity assessment systems
ANSI guidelines (7) - ANSWER✔✔-administration (quality policies, objectives, responsibilities), design
assurance, control of purchased materials, production quality control, user contact and field
performance, corrective action, employee relations
mission of Malcolm Baldridge National Quality Award - ANSWER✔✔-government-mandated award to
reward companies for improving quality, establish guidance for US companies by making detailed
information available on previous winners
criteria for malcolm baldridge award (7) - ANSWER✔✔-leadership, strategic planning, customer and
market focus, measurement/analysis/knowledge management, human resource focus, process
management, business/organizational performance results
process of assessment for baldridge award (4) - ANSWER✔✔-4 1/2 day site visit from examiners, work
with leadership to identify key strengths and opportunities, immediate feedback for organization,
written feedback report
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